An Open-label Single-arm Pharmacokinetic Trial, Investigating the Effect of CYP3A4 inhibitor Ritonavir on the Pharmacokinetics of Erlotinib

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

试验速览

•?1. Patients treated with single agent erlotinib 150mg QD for at least 4 weeks
•?2. Age = 18 years
•?3. Accessible for repeated venipunctures
•?4. Ability to understand the study and give signed informed consent prior to beginning of protocol specific procedures

•?1. Concomitant use of medication(s) which could influence the pharmacokinetics of erlotinib within 14 days or five half-lives of the drug (whichever is shorter) before start of the study, consisting of (but not limited to) CYP3A4-inhibitors/inductors
•?2. Active uncontrolled infection or severe cardiac dysfunction (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina)
•?3. Impaired hepatic function (total bilirubin > ULN or Child-Pugh A, B and C)
•?4. Woman who are pregnant or breast feeding
•?5. Progression on erlotinib at the latest regular response evaluation
•?5. Current smokers

发起方

The Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI-AVL)